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| ID | Type | Description | Link |
|---|---|---|---|
| R44MH094036 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This is an Open-Label Study in Stable Schizophrenia Patients to Evaluate the Safety, Tolerability, and Pharmacokinetics of Switching from Oral Risperidone to Risperidone Implant (DLP-114).
Phase 1 open-label study in stable schizophrenia patients designed to evaluate the safety, tolerability, and Pharmacokinetics of switching from 2 mg/day or 3 mg/day oral risperidone to two DLP-114 devices for a six or twelve-month dosing period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DLP-114 alpha-4 (6-months) | Experimental | Group 1: 6-month implant arm Oral phase: 3mg of Risperidone for 2 weeks Implant phase: 2 implants (360mg of Risperidone per implant) for 6 months |
|
| DLP-114 alpha-7 (12-months) | Experimental | Group 2: 12-month implant arm Oral phase: 3mg of Risperidone for 2 weeks Implant phase: 2 implants (435mg of Risperidone per implant) for 12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risperidone | Combination Product | Risperidone Implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Number of Participants with Treatment-Emergent Adverse Events. | Up to 8 months and up to 15 months for groups 1 and 2 respectively. |
| Percentage of Implant Site Assessments With a Dermal Irritation Scale Rating Greater Than Zero | Evaluate the incidence of local site reactions. Percentage of implant site assessments with a dermal irritation scale rating greater than zero (rating scale is 0 to 4, where 0 indicates no erythema or edema, and 4 indicates erythema or slight eschar). | 6 months and 12 months for groups 1 and 2 respectively. |
| Number of Participants Who Experienced an AE Related to Implantation or Explantation Procedures | Number of participants who experienced an Adverse Events related to Implantation or Explantation Procedures | 6 months and 12 months for groups 1 and 2 respectively. |
| Measure | Description | Time Frame |
|---|---|---|
| Oral Phase Cave: Average Plasma Concentration of Active Moiety (Risperidone + 9 OH Risperidone) During 24 Hours After 3 Days of Repeated 3mg QD Oral Administrations | Oral Phase Cave: Average plasma concentration of active moiety (risperidone + 9 OH risperidone) during 24 hours after 3 days of repeated 3mg QD oral administrations | t=0, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours following oral administration. |
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Inclusion Criteria:
Adult patients 18-70 years of age of both sexes diagnosed with schizophrenia or schizoaffective disorder according to Diagnostic and Statistical Manual (DSM)-V who have been stable on oral risperidone (2mg-3mg) for at least 2 weeks.
Patient (and/or a patient's authorized legal representative) has provided written informed consent
Patient meets the following criteria:
i. Conceptual disorganization ii. Suspiciousness iii. Hallucinatory behavior iv. Unusual thought content v. Hostility d. Clinical Global Impression Scale (CGI-S) ≤ 4 (moderately ill)\Lack of clinically significant suicidal ideation or behavior; Columbia Suicide Severity Rating Scale (C-SSRS) score type of 4-5 require evaluation by mental health professional to ensure patient safety in study
Body Mass Index (BMI) within the range of 18.5 to 40.0 kg/m2 (inclusive);
Ability to understand the nature and objectives of the trial, including risks and adverse events, and be able to read, review and sign the informed consent document prior to conduct of any study procedures;
Willing and able to comply with the requirements of the study protocol; including willingness to visit the clinical facility for all outpatient visits and confinement periods;
Have suitable venous access for blood sampling.
Patient is assessed by the Investigator to be symptomatically stable with regard to pre-existing medical conditions as evidenced by medical history, non-clinically significant findings on physical examination, vital signs, clinical laboratory evaluations (hematology, serum chemistries, and urinalysis) or 12-lead electrocardiogram (ECG). Subjects may continue on their current prescribed medication regimens to control pre-existing medical and psychiatric conditions (other than schizophrenia) including the use of prescribed PRN medications.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Collaborative Neuroscience Research | Long Beach | California | 90806 | United States | ||
| Segal Trials |
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| ID | Title | Description |
|---|---|---|
| FG000 | DLP-114 Alpha-4 (6-months) | Group 1: 6-month implant arm Oral Phase: 3mg of Risperidone for 2 weeks Implant Phase: 2 implants (360 mg of Risperidone per implant) for 6 months |
| FG001 | DLP-114 Alpha-7 (12-months) | Group 2: 12-month implant arm Oral Phase: 3 mg of Risperidone for 2 weeks Implant Phase: 2 implants (435 mg of Risperidone per implant) for 12 months |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Represents the number of participants who completed the oral phase and enrolled in the implant phase.
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| ID | Title | Description |
|---|---|---|
| BG000 | DLP-114 Alpha-4 (6-months) | Group 1: 6-month implant arm Oral Phase: 3 mg of Risperidone for 2 weeks Implant Phase: 2 implants (360 mg of Risperidone per implant) for 6 months |
| BG001 | DLP-114 Alpha-7 (12-months) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Adverse Events | Number of Participants with Treatment-Emergent Adverse Events. | All patients participating in both phases of the study (Oral and implant). | Posted | Count of Participants | Participants | Up to 8 months and up to 15 months for groups 1 and 2 respectively. |
|
Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
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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 | DLP-114 Alpha-4 (6-months) | 2 360mg Risperidone Implants Risperidone: Risperidone Implant |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oedema Peripheral | General disorders | MeDRA 23.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back Pain | Musculoskeletal and connective tissue disorders | MeDRA 23.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eesha Gupta | Delpor, Inc. | 415-289-1770 | eesha.gupta@delpor.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 12, 2021 | Aug 7, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 20, 2022 | Aug 7, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 21, 2021 | Aug 7, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D018967 | Risperidone |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Implant Cave: Average Plasma Concentration of Active Moiety (Risperidone + 9 OH Risperidone) During the Implant Phase | Average plasma concentration of active moiety (risperidone + 9 OH risperidone) following switch from oral risperidone to subcutaneous implantation of two DLP-114 devices at specific time intervals per protocol for 6 months or 12 months (groups 1 and 2 respectively). | PK blood draw & analysis were performed per protocol time intervals; 0, 1, 2, 3, 4, 6, 8, 12, 24, 28, 32, 36, 48, and 52 hours post-placement of implants; 1x/day for 4 additional days, 1x/week during days 5-28; biweekly until day of device removal. |
| Average Positive and Negative Syndrome Scale (PANSS) During the Study (Oral & Implant Phases) | Average Positive and Negative Syndrome Scale (PANSS) during the study (Oral & Implant Phases). The average PANSS score was calculated for each participant during the study. The PANSS score reported is the average of all participants who completed the study in each group. The PANSS provides a total score (sum of the scores of all 30 items) ranging from 30 to 210, higher scores indicate more severe neuropsychiatric symptoms of schizophrenia. Scores for 3 subscales, that is, for positive subscale (sum of the scores of all 7 items) and negative subscale (sum of the scores of all 7 items) ranges from 7 (absent) to 49 (extreme psychopathology), and for the general psychopathology subscale (sum of the scores of all 16 items) score ranges from 16 (absent) to 112 (extreme psychopathology) | For group 1: Screening period, day -1, day 84, day 183; and for Group 2: Screening period, day -1, day 84, day 182, day 280, day 364. |
| Average Clinical Global Impression-Improvement (CGI-I) Scale During the Implant Phase | Average Clinical Global Impression-Improvement (CGI-I) Scale during the Implant Phase. The average CGI-I score was calculated for each participant during the Implant Phase. The CGI-I score reported is the average of all participants who completed the study in each group. The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. | CGI-I assessments were conducted over the course of the study per the protocol schedule of assessments. For Group 1: day 7, 14, 28, 42, 70, 112,140, 68, 183 and for Group 2: day 7, 14, 28, 56, 84, 112,140, 168,182, 210, 238, 252, 280, 308, 336, 350, 364. |
| Average Daily Risperidone Implant Output During the Implant Phase | Average daily Risperidone Implant output during the Implant Phase. Average daily output is calculated by using the amount of Risperidone drug substance remaining in the DLP-114 reservoir following removal. The average daily output is calculated for each participant by using the two devices that each participant received. Risperidone output reported as the average for each group. | 6-months and 12-months for groups 1 and 2 respectively. Remaining Risperidone measurements taken at the end of the Implant Phase. |
| Implant Device Placement Depth | Average depth of implant device placement measured by ultrasound in mm. The average depth was calculated for each participant. The implant device depth reported is the average of all participants who completed the study in each group. | Group 1 (6-month): Ultrasound on days 14 and 183. Group 2 (12-month): Ultrasound on days 14 and 364. |
| Number of Participants Who Experienced Implant Migration in at Least One of the Implanted Devices | Implant migration is defined as a distance of greater than 3cm between the initial incision and the proximal end of the implant device prior to removal. | Group 1 (6-month): Assessments performed day 1 and day 183. Group 2 (12-month): Assessments performed day 1 and 364. |
| Miami Lakes |
| Florida |
| 33016 |
| United States |
Group 2: 12-month implant arm
Oral Phase: 3 mg of Risperidone for 2 weeks
Implant Phase: 2 implants (435 mg of Risperidone per implant) for 12 months
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Primary | Percentage of Implant Site Assessments With a Dermal Irritation Scale Rating Greater Than Zero | Evaluate the incidence of local site reactions. Percentage of implant site assessments with a dermal irritation scale rating greater than zero (rating scale is 0 to 4, where 0 indicates no erythema or edema, and 4 indicates erythema or slight eschar). | Participants who enrolled in the implant phase of the study, | Posted | Number | percentage of site assessments rated >0 | 6 months and 12 months for groups 1 and 2 respectively. | Implant site assessments | Implant site assessments |
|
|
|
| Primary | Number of Participants Who Experienced an AE Related to Implantation or Explantation Procedures | Number of participants who experienced an Adverse Events related to Implantation or Explantation Procedures | Patients who started the implant phase | Posted | Count of Participants | Participants | 6 months and 12 months for groups 1 and 2 respectively. |
|
|
|
| Secondary | Oral Phase Cave: Average Plasma Concentration of Active Moiety (Risperidone + 9 OH Risperidone) During 24 Hours After 3 Days of Repeated 3mg QD Oral Administrations | Oral Phase Cave: Average plasma concentration of active moiety (risperidone + 9 OH risperidone) during 24 hours after 3 days of repeated 3mg QD oral administrations | Participants who completed the Oral Dose Phase and began the Implant Phase. | Posted | Mean | Standard Deviation | ng/mL | t=0, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours following oral administration. | Plasma Measurement | Plasma Measurement |
|
|
|
| Secondary | Implant Cave: Average Plasma Concentration of Active Moiety (Risperidone + 9 OH Risperidone) During the Implant Phase | Average plasma concentration of active moiety (risperidone + 9 OH risperidone) following switch from oral risperidone to subcutaneous implantation of two DLP-114 devices at specific time intervals per protocol for 6 months or 12 months (groups 1 and 2 respectively). | Participants who completed the study. | Posted | Mean | Standard Deviation | ng/ML | PK blood draw & analysis were performed per protocol time intervals; 0, 1, 2, 3, 4, 6, 8, 12, 24, 28, 32, 36, 48, and 52 hours post-placement of implants; 1x/day for 4 additional days, 1x/week during days 5-28; biweekly until day of device removal. | Plasma Measurement | Plasma Measurement |
|
|
|
| Secondary | Average Positive and Negative Syndrome Scale (PANSS) During the Study (Oral & Implant Phases) | Average Positive and Negative Syndrome Scale (PANSS) during the study (Oral & Implant Phases). The average PANSS score was calculated for each participant during the study. The PANSS score reported is the average of all participants who completed the study in each group. The PANSS provides a total score (sum of the scores of all 30 items) ranging from 30 to 210, higher scores indicate more severe neuropsychiatric symptoms of schizophrenia. Scores for 3 subscales, that is, for positive subscale (sum of the scores of all 7 items) and negative subscale (sum of the scores of all 7 items) ranges from 7 (absent) to 49 (extreme psychopathology), and for the general psychopathology subscale (sum of the scores of all 16 items) score ranges from 16 (absent) to 112 (extreme psychopathology) | Participants who completed the study. | Posted | Mean | Standard Deviation | Total score on PANSS scale | For group 1: Screening period, day -1, day 84, day 183; and for Group 2: Screening period, day -1, day 84, day 182, day 280, day 364. | Individual PANSS Score Assessment | Individual PANSS Score Assessment |
|
|
|
| Secondary | Average Clinical Global Impression-Improvement (CGI-I) Scale During the Implant Phase | Average Clinical Global Impression-Improvement (CGI-I) Scale during the Implant Phase. The average CGI-I score was calculated for each participant during the Implant Phase. The CGI-I score reported is the average of all participants who completed the study in each group. The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. | Participants who completed the study | Posted | Mean | Full Range | Score on CGI-I scale | CGI-I assessments were conducted over the course of the study per the protocol schedule of assessments. For Group 1: day 7, 14, 28, 42, 70, 112,140, 68, 183 and for Group 2: day 7, 14, 28, 56, 84, 112,140, 168,182, 210, 238, 252, 280, 308, 336, 350, 364. | Individual CGI-I Assessment | Individual CGI-I Assessment |
|
|
|
| Secondary | Average Daily Risperidone Implant Output During the Implant Phase | Average daily Risperidone Implant output during the Implant Phase. Average daily output is calculated by using the amount of Risperidone drug substance remaining in the DLP-114 reservoir following removal. The average daily output is calculated for each participant by using the two devices that each participant received. Risperidone output reported as the average for each group. | Participants who completed the study. | Posted | Mean | Standard Deviation | mg/day | 6-months and 12-months for groups 1 and 2 respectively. Remaining Risperidone measurements taken at the end of the Implant Phase. | Implant Devices | Implant Devices |
|
|
|
| Secondary | Implant Device Placement Depth | Average depth of implant device placement measured by ultrasound in mm. The average depth was calculated for each participant. The implant device depth reported is the average of all participants who completed the study in each group. | Participants who completed the study | Posted | Mean | Standard Deviation | mm | Group 1 (6-month): Ultrasound on days 14 and 183. Group 2 (12-month): Ultrasound on days 14 and 364. | Implant Devices | Implant Devices |
|
|
|
| Secondary | Number of Participants Who Experienced Implant Migration in at Least One of the Implanted Devices | Implant migration is defined as a distance of greater than 3cm between the initial incision and the proximal end of the implant device prior to removal. | Participants who completed the study. | Posted | Number | number of participants | Group 1 (6-month): Assessments performed day 1 and day 183. Group 2 (12-month): Assessments performed day 1 and 364. |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 10 |
| 14 |
| EG001 | DLP-114 Alpha-7 (12-months) | 2 435mg Risperidone Implants Risperidone: Risperidone Implant | 0 | 14 | 1 | 14 | 12 | 14 |
| Weight Increase | Investigations | MeDRA 23.1 | Non-systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MeDRA 23.1 | Non-systematic Assessment |
|
| Cardiac Failure Congestive | Cardiac disorders | MeDRA 23.1 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MeDRA 23.1 | Non-systematic Assessment |
|
| Implant site haemorrhage | General disorders | MeDRA 23.1 | Non-systematic Assessment |
|
| Injection Site Scar | General disorders | MeDRA 23.1 | Non-systematic Assessment |
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| Implant site pain | General disorders | MeDRA 23.1 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MeDRA 23.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MeDRA 23.1 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MeDRA 23.1 | Non-systematic Assessment |
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| Chest Pain | General disorders | MeDRA 23.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MeDRA 23.1 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MeDRA 23.1 | Non-systematic Assessment |
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| Ecchymosis | Skin and subcutaneous tissue disorders | MeDRA 23.1 | Non-systematic Assessment |
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| Weight increased | Investigations | MeDRA 23.1 | Non-systematic Assessment |
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| Implant Site pruritus | General disorders | MeDRA 23.1 | Non-systematic Assessment |
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| Ankle Fracture | Injury, poisoning and procedural complications | MeDRA 23.1 | Non-systematic Assessment |
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| Injection site discomfort | General disorders | MeDRA 23.1 | Non-systematic Assessment |
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| Paresthesia Oral | Gastrointestinal disorders | MeDRA 23.1 | Non-systematic Assessment |
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| Abdominal Discomfort | Gastrointestinal disorders | MeDRA 23.1 | Non-systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MeDRA 23.1 | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | MeDRA 23.1 | Non-systematic Assessment |
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| Toothache | Gastrointestinal disorders | MeDRA 23.1 | Non-systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | MeDRA 23.1 | Non-systematic Assessment |
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| Increased appetite | Metabolism and nutrition disorders | MeDRA 23.1 | Non-systematic Assessment |
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| Ear infection | Infections and infestations | MeDRA 23.1 | Non-systematic Assessment |
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| Abnormal behavior | Psychiatric disorders | MeDRA 23.1 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MeDRA 23.1 | Non-systematic Assessment |
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| Tachycardia | Cardiac disorders | MeDRA 23.1 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MeDRA 23.1 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MeDRA 23.1 | Non-systematic Assessment |
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| Pain in Extremity | Musculoskeletal and connective tissue disorders | MeDRA 23.1 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MeDRA 23.1 | Non-systematic Assessment |
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| Polycythaemia | Blood and lymphatic system disorders | MeDRA 23.1 | Non-systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MeDRA 23.1 | Non-systematic Assessment |
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| Arthropod bite | Injury, poisoning and procedural complications | MeDRA 23.1 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MeDRA 23.1 | Non-systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MeDRA 23.1 | Non-systematic Assessment |
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| Ligament Sprain | Injury, poisoning and procedural complications | MeDRA 23.1 | Non-systematic Assessment |
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| Testicular pain | Respiratory, thoracic and mediastinal disorders | MeDRA 23.1 | Non-systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MeDRA 23.1 | Non-systematic Assessment |
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| Hordeolum | Infections and infestations | MeDRA 23.1 | Non-systematic Assessment |
|
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