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To date, there are no published data on the role of melatonin supplementation or the appropriate dose for patients with multiple sclerosis. Because of the potential benefits of melatonin, this pilot study will be an exploratory investigation to evaluate the effect of supplementing melatonin in subjects with multiple sclerosis who are taking an oral disease modifying therapy (DMT) for 6 months or longer. It is our intent that the results of this study will support the rationale and be a prelude to a larger trial which can focus on clinical efficacy of melatonin therapy outcomes.
The primary objective of this study is to evaluate the change in 24 hour urinary 6-sulfatoxymelatonin (6SMT) collected for 24 hours in two twelve hour sessions. The secondary objectives are to evaluate the change in serum morning melatonin level. In addition, quality of life (QOL) measures will be assessed including the Modified Fatigue Impact Scale (MFIS), Multiple Sclerosis Impact Scale (MSIS-29), and the Pittsburgh Sleep Quality Index (PSQI). Clinical objectives include the number of relapses during the trial and a change in the Patient Determined Disease Steps (PDDS) & Performance Scales (PS).
The pilot study is a one-year randomized, rater- and dose-blinded trial evaluating the potential role of melatonin in subjects with relapsing multiple sclerosis who have been taking a stable dose of an oral disease modifying therapy (DMT) for at least 6 months. The oral DMTs include dimethyl fumarate, fingolimod, teriflunomide, diroximel fumarate, siponimod, and ozanimod. Thirty subjects with relapsing forms of multiple sclerosis who meet all of the eligibility criteria will be enrolled at Providence Neurological Specialties in Portland, Oregon.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3 mg Melatonin | Experimental | Subjects will receive 3 mg melatonin once a day. |
|
| 5 mg Melatonin | Experimental | Subjects will receive 5 mg melatonin once a day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3 mg Melatonin | Drug | 3 mg melatonin once each day |
| |
| 5 mg Melatonin |
| Measure | Description | Time Frame |
|---|---|---|
| Urine Melatonin Levels | Changes in urinary 6-SMT in 24 hours, urine measured in nanograms per gram of creatinine | Baseline (month 0), Month 3, Month 6, and Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Fatigue Impact Scale (MFIS) | Changes in the MFIS: Modified Fatigue Impact Scale (MFIS) is a PRO, consisting of 21 statements that describe the effect of fatigue. Subject will choose an answer (0= never to 4=always) that best describes how fatigue has affected them in the past 4 weeks. Item scores are summed to a total score. The total MFIS score ranges from 0 to 84, with three subscales: Physical range 0-36, Cognitive range 0-40, and Psychosocial range 0-8. Higher scores indicate higher level of fatigue. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyle Smoot, MD | Providence Health & Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Providence MS Center | Portland | Oregon | 97225 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39126937 | Derived | Smoot K, Gervasi-Follmar T, Marginean H, Chen C, Cohan S. Impact of oral melatonin supplementation on urine and serum melatonin concentrations and quality-of-life measures in persons with relapsing multiple sclerosis. Mult Scler Relat Disord. 2024 Oct;90:105799. doi: 10.1016/j.msard.2024.105799. Epub 2024 Aug 3. | |
| 35355991 | Derived |
| Label | URL |
|---|---|
| Providence Brain and Spine Institute | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 3 mg Melatonin | Subjects will receive 3 mg melatonin once a day. 3 mg Melatonin: 3 mg melatonin once each day |
| FG001 | 5 mg Melatonin | Subjects will receive 5 mg melatonin once a day. 5 mg Melatonin: 5 mg Melatonin once each day |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 3 mg Melatonin | Subjects will receive 3 mg melatonin once a day. 3 mg Melatonin: 3 mg melatonin once each day |
| BG001 | 5 mg Melatonin | Subjects will receive 5 mg melatonin once a day. 5 mg Melatonin: 5 mg Melatonin once each day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Urine Melatonin Levels | Changes in urinary 6-SMT in 24 hours, urine measured in nanograms per gram of creatinine | Number analyzed in one or more rows differs from overall number analyzed due to patients withdrawing or being withdrawn throughout the course of the study. Numbers analyzed in serum and urine outcomes may differ in the numbers analyzed in the questionnaire outcomes (PSQI,MFIS,MSIS-29, PDDS-PS) due to patients completing questionnaires but samples not being collected or analyzed. | Posted | Median | Inter-Quartile Range | nanograms per gram of creatinine | Baseline (month 0), Month 3, Month 6, and Month 12 |
|
The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 3 mg Melatonin | Subjects will receive 3 mg melatonin once a day. 3 mg Melatonin: 3 mg melatonin once each day |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Near-syncope | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of PBSI /WC Clinical Research Program | Providence Health & Services | (503) 216-1012 | Chiayi.Chen@providence.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 9, 2020 | Mar 21, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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Subjects will be randomly assigned to receive melatonin at 3 milligrams (mg) once a day or 5mg once a day. The study drug will be taken at 21:00 each day ± 2 hours.
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The study is blinded to patients and providers.
| Drug |
5 mg Melatonin once each day |
|
| Baseline (month 0), Month 3, Month 6, and Month 12 |
| Serum Melatonin Level | Changes in morning blood levels of melatonin | Baseline (month 0), Month 3, Month 6, and Month 12 |
| Multiple Sclerosis Impact Scale-29 (MSIS-29) | Multiple Sclerosis Impact Scale (MSIS) is a patient reported outcome (PRO) measure, consisting of two subscales- physical impact of MS (20 items) and psychological impact (9 items). It asks subject to rate the impact MS has their daily life in the past 2 weeks (1=low impact to 4=large impact). Individual item scores are summed to create a raw score, which is then transformed on a scale from 0 to 100 for each subscale. Higher scores indicate greater impact of MS on QoL. | Baseline (month 0), Month 3, Month 6, and Month 12 |
| Pittsburgh Sleep Quality Index (PSQI) | Changes in PSQI: Pittsburgh Sleep Quality Index (PSQI) asks 10 sets of questions about sleep quality and pattern in the past month. The scale derive 7 component scores based on a 0 to 3 scale (0= no difficulty, 3=severe difficulty) which are summed to a global score (range 0 to 21). Higher scores indicates worse sleep quality. | Baseline (month 0), Month 3, Month 6, and Month 12 |
| Relapse Rate | Number of MS relapses during study | 12 months |
| Patient Determined Disease Steps - Performance Scale (PDDS-PS) | Changes in PDDS-PS: Patient Determined Disease Steps and Performance Scales (PDDS-PS) is a PRO for MS disease status. Performance Scales (PS) has 8 subscales: mobility range, hand function range, vision range, fatigue range, cognition range, bowel/bladder range, sensory range, and spasticity range. Subject self-classify their level of disability on a 0 to 8 scale (0=Normal to 8=Bedridden) with 8 being the most disabled for PDDS. For Performance Scales (PS) subject self-classify their level of disability on a 0 to 6 scale (0=Normal to 6=Bedridden) with 6 being the most disabled for PS - Mobility. Subject self-classify their level of disability on 0 to 5 scale (0=Normal to 5=Total Disability) with 5 being the most disabled for PS - hand function range, vision range, fatigue range, cognition range, bowel/bladder range, sensory range, and spasticity range. | Baseline (month 0), Month 3, Month 6, and Month 12 |
| Ghareghani M, Farhadi Z, Rivest S, Zibara K. PDK4 Inhibition Ameliorates Melatonin Therapy by Modulating Cerebral Metabolism and Remyelination in an EAE Demyelinating Mouse Model of Multiple Sclerosis. Front Immunol. 2022 Mar 9;13:862316. doi: 10.3389/fimmu.2022.862316. eCollection 2022. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Prior MS treatment Received | Count of Participants | Participants |
|
| 5 mg Melatonin |
Subjects will receive 5 mg melatonin once a day. 5 mg Melatonin: 5 mg Melatonin once each day |
|
|
| Secondary | Modified Fatigue Impact Scale (MFIS) | Changes in the MFIS: Modified Fatigue Impact Scale (MFIS) is a PRO, consisting of 21 statements that describe the effect of fatigue. Subject will choose an answer (0= never to 4=always) that best describes how fatigue has affected them in the past 4 weeks. Item scores are summed to a total score. The total MFIS score ranges from 0 to 84, with three subscales: Physical range 0-36, Cognitive range 0-40, and Psychosocial range 0-8. Higher scores indicate higher level of fatigue. | Number analyzed in one or more rows differs from overall number analyzed due to patients withdrawing or being withdrawn throughout the course of the study. | Posted | Mean | Inter-Quartile Range | scores on a MFIS scale | Baseline (month 0), Month 3, Month 6, and Month 12 |
|
|
|
| Secondary | Serum Melatonin Level | Changes in morning blood levels of melatonin | Number analyzed in one or more rows differs from overall number analyzed due to patients withdrawing or being withdrawn throughout the course of the study. Numbers analyzed in serum and urine outcomes may differ in the numbers analyzed in the questionnaire outcomes (PSQI,MFIS,MSIS-29, PDDS-PS) due to patients completing questionnaires but samples not being collected or analyzed. | Posted | Median | Inter-Quartile Range | pg/ml | Baseline (month 0), Month 3, Month 6, and Month 12 |
|
|
|
| Secondary | Multiple Sclerosis Impact Scale-29 (MSIS-29) | Multiple Sclerosis Impact Scale (MSIS) is a patient reported outcome (PRO) measure, consisting of two subscales- physical impact of MS (20 items) and psychological impact (9 items). It asks subject to rate the impact MS has their daily life in the past 2 weeks (1=low impact to 4=large impact). Individual item scores are summed to create a raw score, which is then transformed on a scale from 0 to 100 for each subscale. Higher scores indicate greater impact of MS on QoL. | Number analyzed in one or more rows differs from overall number analyzed due to patients withdrawing or being withdrawn throughout the course of the study. | Posted | Median | Inter-Quartile Range | MSIS-29 Score | Baseline (month 0), Month 3, Month 6, and Month 12 |
|
|
|
| Secondary | Pittsburgh Sleep Quality Index (PSQI) | Changes in PSQI: Pittsburgh Sleep Quality Index (PSQI) asks 10 sets of questions about sleep quality and pattern in the past month. The scale derive 7 component scores based on a 0 to 3 scale (0= no difficulty, 3=severe difficulty) which are summed to a global score (range 0 to 21). Higher scores indicates worse sleep quality. | Number analyzed in one or more rows differs from overall number analyzed due to patients withdrawing or being withdrawn throughout the course of the study. | Posted | Median | Inter-Quartile Range | PSQI Score | Baseline (month 0), Month 3, Month 6, and Month 12 |
|
|
|
| Secondary | Relapse Rate | Number of MS relapses during study | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Patient Determined Disease Steps - Performance Scale (PDDS-PS) | Changes in PDDS-PS: Patient Determined Disease Steps and Performance Scales (PDDS-PS) is a PRO for MS disease status. Performance Scales (PS) has 8 subscales: mobility range, hand function range, vision range, fatigue range, cognition range, bowel/bladder range, sensory range, and spasticity range. Subject self-classify their level of disability on a 0 to 8 scale (0=Normal to 8=Bedridden) with 8 being the most disabled for PDDS. For Performance Scales (PS) subject self-classify their level of disability on a 0 to 6 scale (0=Normal to 6=Bedridden) with 6 being the most disabled for PS - Mobility. Subject self-classify their level of disability on 0 to 5 scale (0=Normal to 5=Total Disability) with 5 being the most disabled for PS - hand function range, vision range, fatigue range, cognition range, bowel/bladder range, sensory range, and spasticity range. | Number analyzed in one or more rows differs from overall number analyzed due to patients withdrawing or being withdrawn throughout the course of the study. | Posted | Median | Inter-Quartile Range | scores on a PDDS-PS scale | Baseline (month 0), Month 3, Month 6, and Month 12 |
|
|
|
| 0 |
| 15 |
| 1 |
| 15 |
| 14 |
| 15 |
| EG001 | 5 mg Melatonin | Subjects will receive 5 mg melatonin once a day. 5 mg Melatonin: 5 mg Melatonin once each day | 0 | 15 | 0 | 15 | 15 | 15 |
| Pacemaker insertion | Cardiac disorders | Systematic Assessment |
|
| Heart block | Cardiac disorders | Systematic Assessment |
|
| FLU LIKE SYMPTOMS AFTER 2ND SHINGRIX VACCINE | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Acute Sinusitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Acute viral syndrome with ageusia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Acute non-reccurrent frontal sinusitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Sleep Apnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Essential hypertension | Cardiac disorders | Systematic Assessment |
|
| Type II diabetes | Endocrine disorders | Systematic Assessment |
|
| NIGHT SWEATS | Endocrine disorders | Systematic Assessment |
|
| Thyroid lobectomy | Endocrine disorders | Systematic Assessment |
|
| Thyroid/neck nodule increasing in size | Endocrine disorders | Systematic Assessment |
|
| Elevated liver function test | Blood and lymphatic system disorders | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Worsening hypercholesterolemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Cold Sore, Right Upper Lip | Infections and infestations | Systematic Assessment |
|
| POSITIVE JCV INDEX | Infections and infestations | Systematic Assessment |
|
| Shingles | Infections and infestations | Systematic Assessment |
|
| COVID Infection | Infections and infestations | Systematic Assessment |
|
| LOSS OF TONE/SORENESS, LEFT GLUTEUS MUSCLE | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| WORSENING OF LEG WEAKNESS, UPPER LEFT THIGH/QUAD, BILATERAL | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| SLIGHT DECREASE IN HAND DEXTERITY, LEFT | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| LOW BACK PINCHING SENSATION | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| BROKEN FINGER, LEFT HAND, 5TH FINGER | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| WEAKNESS, GENERALIZED | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| NECK PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Tenderness, left plantar surface of foot | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| DUPUYTREN'S CONTRACTURE, BILATERAL HANDS | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Right foot pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pain, lower extremities | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Weakness/tightness, lower extremities | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Medial left knee pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| RIGHT ANKLE TENDONITIS | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Osteopenia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Ankle sprain, left | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Hemorrhoids | Gastrointestinal disorders | Systematic Assessment |
|
| STOMACH UPSET | Gastrointestinal disorders | Systematic Assessment |
|
| NAUSEA, SECONDARY TO WEAKNESS | Gastrointestinal disorders | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | Systematic Assessment |
|
| BOWEL URGENCY | Gastrointestinal disorders | Systematic Assessment |
|
| Adenomatous polyp, colon | Gastrointestinal disorders | Systematic Assessment |
|
| Exertional nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Increased Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| DRY MOUTH | Gastrointestinal disorders | Systematic Assessment |
|
| VISION CHANGES | Eye disorders | Systematic Assessment |
|
| Sore on tongue | Gastrointestinal disorders | Systematic Assessment |
|
| LESION,RIGHT POSTERIOR DORSAL TONGUE | Gastrointestinal disorders | Systematic Assessment |
|
| Tooth infection | Infections and infestations | Systematic Assessment |
|
| Pharyngoesophageal dysphagia | Gastrointestinal disorders | Systematic Assessment |
|
| tooth abscess | Gastrointestinal disorders | Systematic Assessment |
|
| BILATERAL RECTUS RECESSION 9.0MM W/ADJUSTABLE SUTURE, LEFT EYE | Eye disorders | Systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Temperature related pain, mouth | Gastrointestinal disorders | Systematic Assessment |
|
| Ear Infection | Ear and labyrinth disorders | Systematic Assessment |
|
| FATIGUE SECONDARY TO MELATONIN | General disorders | Systematic Assessment |
|
| WORSENING OF BALANCE ISSUES | General disorders | Systematic Assessment |
|
| CHILLS | General disorders | Systematic Assessment |
|
| HOT FLASHES | General disorders | Systematic Assessment |
|
| Intermittent balance issues | General disorders | Systematic Assessment |
|
| Shivering secondary to 2nd covid vaccine | General disorders | Systematic Assessment |
|
| Groggy in the mornings | General disorders | Systematic Assessment |
|
| Increased balance difficulties | General disorders | Systematic Assessment |
|
| Increased Weakness | General disorders | Systematic Assessment |
|
| Worsening increased weakness | General disorders | Systematic Assessment |
|
| Worsening increased balance difficulties | General disorders | Systematic Assessment |
|
| Increased fatigue | General disorders | Systematic Assessment |
|
| Worsening increased fatigue | General disorders | Systematic Assessment |
|
| BASAL CELL CARCINOMA, RIGHT CHEEK | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| PAIN SECONDARY TO BASAL CELL CARCINOMA REMOVAL, RIGHT CHEEK | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| BASAL CELL CARCINOMA, RIGHT CHEEK, REMOVAL | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| SENSORY DISTURBANCE RIGHT CHEEK, SECONDARY TO BASAL CELL CARCINOMA REMOVAL | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| WELL HEALED SCAR SECONDARY TO BASAL CARCINOMA REMOVAL | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| SPITZ NEVUS,RIGHT ANTERIOR LATERAL ARM, BIOPSY | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| NEOPLASM, UNSPECIFIED, BIOPSY RIGHT ANTERIOR LATERAL ARM | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| DERMATOFIBROMA, RIGHT BUTTOCK | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| LENTIGO | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| CHERRY ANGIOMA | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| XEROSIS | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| SPITZ NEVUS, RIGHT ANTERIOR LATERAL ARM | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| GIANT COMEDONE | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| SEBORRHEIC KERATOSIS | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash, lower left buttocks | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Mild edema, bilateral legs | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Focal spongiotic dermatitis with many eosinophils | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Worsening of rash, multiple diffuse locations | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| SKIN SPLIT BETWEEN D1 AND D2 RIGHT FOOT | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| GENERALIZED DRYNESS | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Contact dermatitis, nose | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Cyst removal incision infection, back | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Cyst removal, back | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Epidemal inclusion cyst | Surgical and medical procedures | Systematic Assessment |
|
| Onychomyosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Tinea pedis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash, facial | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Scaring, extremities | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| left labial cysts | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Toe nail fungus, right | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| General pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Chilblains, bilateral arms | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Squamous cell in situ, scalp | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| POSSIBLE URINARY TRACT INFECTION | Renal and urinary disorders | Systematic Assessment |
|
| POSSIBLE URINARY RETENTION | Renal and urinary disorders | Systematic Assessment |
|
| INTERMITTENT IRREGULAR MENSTRUAL CYCLES | Renal and urinary disorders | Systematic Assessment |
|
| IRREGULAR MENSTRUAL BLEEDING | Renal and urinary disorders | Systematic Assessment |
|
| Increased urinary urgency | Renal and urinary disorders | Systematic Assessment |
|
| Yeast infection | Renal and urinary disorders | Systematic Assessment |
|
| Cervical friability/lesion (benign) | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| vaginal prolapse | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Urinary tract infection | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Intermittent Urinary Hesitancy | Renal and urinary disorders | Systematic Assessment |
|
| WORSENING OF FATIGUE | Psychiatric disorders | Systematic Assessment |
|
| INCREASED FATIGUE | Psychiatric disorders | Systematic Assessment |
|
| IRRITABILITY | Psychiatric disorders | Systematic Assessment |
|
| WORSENING DEPRESSION | Psychiatric disorders | Systematic Assessment |
|
| RESTLESS SLEEP | Psychiatric disorders | Systematic Assessment |
|
| SLEEP ISSUES | Psychiatric disorders | Systematic Assessment |
|
| INCREASED DREAMING | Psychiatric disorders | Systematic Assessment |
|
| Increased stress | Psychiatric disorders | Systematic Assessment |
|
| Worsening insomnia | Psychiatric disorders | Systematic Assessment |
|
| Increased anxiety | Psychiatric disorders | Systematic Assessment |
|
| Intermittent sleep issues | Psychiatric disorders | Systematic Assessment |
|
| SLEEP DISTURBANCES | Psychiatric disorders | Systematic Assessment |
|
| ANXIETY/MOOD DISTURBANCES | Psychiatric disorders | Systematic Assessment |
|
| Restless during the night, unable to fall asleep | Psychiatric disorders | Systematic Assessment |
|
| TWO NEW ENHANCING BRAIN LESIONS | Nervous system disorders | Systematic Assessment |
|
| WORD FINDING ISSUES | Nervous system disorders | Systematic Assessment |
|
| RADIATING PAIN, LOW BACK DOWN RIGHT LEG | Nervous system disorders | Systematic Assessment |
|
| INTERMITTENT TINGLING BILATERAL FEET | Nervous system disorders | Systematic Assessment |
|
| CONCUSSION | Nervous system disorders | Systematic Assessment |
|
| DIZZINESS, SECONDARY TO WEAKNESS | Nervous system disorders | Systematic Assessment |
|
| Intermittent dizziness | Nervous system disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| INCREASED HEADACHES | Nervous system disorders | Systematic Assessment |
|
| INCREASED RESTLESS LEG SYNDROME | Nervous system disorders | Systematic Assessment |
|
| NUMBNESS BACK OF TONGUE | Nervous system disorders | Systematic Assessment |
|
| INTERMITTENT SENSORY DISTURBANCE, HEAD | Nervous system disorders | Systematic Assessment |
|
| Increased numbness, toes | Nervous system disorders | Systematic Assessment |
|
| Trigeminal neuralgia | Nervous system disorders | Systematic Assessment |
|
| headaches upon waking in morning | Nervous system disorders | Systematic Assessment |
|
| Worsening Memory Disorder | Nervous system disorders | Systematic Assessment |
|
| Worsening Trigeminal Neuralgia | Nervous system disorders | Systematic Assessment |
|
| Carpel tunnel, left | Nervous system disorders | Systematic Assessment |
|
| Median Neuropathy, Left Hand | Nervous system disorders | Systematic Assessment |
|
Not provided
Not provided
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| MFIS Score [0-84] - 3 months visit |
|
|
| MFIS Score [0-84] - 6 months visit |
|
|
| MFIS Score [0-84] - 12 months visit |
|
|
| Month 3 |
|
|
| Month 6 |
|
|
| Month 12 |
|
|
| Physical - 3 Months Visit |
|
|
| Physical - 6 months visit |
|
|
| Physical - 12 months visit |
|
|
| Psychological - Baseline |
|
|
| Psychological - 3 months visit |
|
|
| Psychological - 6 months visit |
|
|
| Psychological - 12 months visit |
|
|
| PSQI Global - 3 month Visit |
|
|
| PSQI Global - 6 months visit |
|
|
| PSQI Global - 12 month Visit |
|
|
| Patient Determined Disease Steps - 3 Month Visit |
|
|
| Patient Determined Disease Steps - 6 Month Visit |
|
|
| Patient Determined Disease Steps - 12 Month Visit |
|
|
| Performance Scale - Mobility - Baseline |
|
|
| Performance Scale - Mobility - 3 Month |
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| Performance Scale - Mobility - 6 Month |
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| Performance Scale - Mobility - 12 Month |
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| Performance Scale - Hand Function - Baseline |
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| Performance Scale - Hand Function - 3 Month |
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| Performance Scale - Hand Function - 6 Month |
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| Performance Scale - Hand Function - 12 Month |
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| Performance Scale - Vision Range - Baseline |
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| Performance Scale - Vision Range - 3 Month |
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| Performance Scale - Vision Range - 6 Month |
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| Performance Scale - Vision Range - 12 Month |
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| Performance Scale - Fatigue - Baseline |
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| Performance Scale - Fatigue - 3 Month |
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| Performance Scale - Fatigue - 6 Month |
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| Performance Scale - Fatigue - 12 Month |
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| Performance Scale - Cognition Range - Baseline |
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| Performance Scale - Cognition Range - 3 Month |
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| Performance Scale - Cognition Range - 6 Month |
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| Performance Scale - Cognition Range - 12 Month |
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| Performance Scale - Bowel/Bladder Range - Baseline |
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| Performance Scale - Bowel/Bladder Range - 3 Month |
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| Performance Scale - Bowel/Bladder Range - 6 Month |
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| Performance Scale - Bowel/Bladder Range - 12 Month |
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| Performance Scale - Sensory Range - Baseline |
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| Performance Scale - Sensory Range - 3 Month |
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| Performance Scale - Sensory Range - 6 Month |
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| Performance Scale - Sensory Range - 12 Month |
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| Performance Scale - Spasticity - Baseline |
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| Performance Scale - Spasticity - 3 Month |
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| Performance Scale - Spasticity - 6 Month |
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| Performance Scale - Spasticity - 12 Month |
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