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| Name | Class |
|---|---|
| Syneos Health | OTHER |
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A Multi-Centered Randomized, Double-Blind, Placebo-Controlled, Phase 2, Exploratory Study to Evaluate the Effect of Rufinamide on Anxiety in Patients with Moderate to Severe Generalized Anxiety Disorder.
This was an exploratory study to evaluate the effect of 500 or 1000 mg per day for 8 weeks of Rufinamide compared to placebo on measures of anxiety in patients with Generalized Anxiety Disorder, and to determine tolerability of Rufinamide in this population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SYN111 | Experimental | 500 mg 1 week, followed by 1000 mg for 7 weeks |
|
| Placebo | Placebo Comparator | 0 mg tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SYN111 | Drug | 500 mg for 1 week followed by 1000 mg for 7 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hamilton Anxiety Scale (HAMA) - Total Score: Summary Statistics - Observed | The Hamilton Anxiety Scale is a 14-item test measuring the severity of anxiety symptoms. It provides measures of overall anxiety, psychic anxiety (mental agitation and psychological distress), and somatic anxiety (physical complaints related to anxiety). The interviewer then rated the individuals on a 5-point scale for each of the 14 items. Seven of the items specifically address psychic anxiety and the remaining 7 items address somatic anxiety. The total anxiety score ranges from 0 to 56. The 7 psychic anxiety items elicit a psychic anxiety score that ranges from 0 to 28. The remaining 7 items yield a somatic anxiety score that also ranges from 0 to 28. A score of 17 or less indicates mild anxiety severity. A score from 18 to 24 indicates mild to moderate anxiety severity, a score of 25 to 30 indicates a moderate to severe anxiety and lastly a score of 31-56 is very severe. HAM-A total score is the sum of items 1 - 14. | 8 Weeks |
| Change From Baseline in Hospital Anxiety and Depression Scale (HADS). Summary Statistics | The Hospital Anxiety and Depression Scale is a self screening questionnaire for depression and anxiety. It consists of 14 questions, seven for anxiety and seven for depression. The 14 statements are relevant to either generalized anxiety (7 statements) or 'depression' (again 7). Each question has 4 possible responses. Responses are scored on a scale from 3 to 0. The maximum score is therefore 21 for depression and 21 for anxiety. A score of 11 or higher indicates the probable presence of the mood disorder with a score of 8 to 10 being just suggestive of the presence of the respective state. The 2 subscales, anxiety and depression, have been found to be independent measures. In its current form the HADS is now divided into 4 ranges: normal (0-7), mild (8-10), moderate (11-15) and severe (16-21). Anxiety score = sum of items 1, 3, 5, 7, 9, 11, and 13. Depression score = sum of items 2, 4, 6, 8, 10, 12, and 14. | 8 Weeks |
| Change From Baseline in Montgomery-Asberg Depression Scale (MADRS) Summary Statistics. | The MADRS (Montgomery and Asberg 1979) is a clinician-rated instrument that measures the presence and severity of depression. This instrument consists of 10 items. Each item is rated on a defined step scale of 0 to 6 with anchors at 2-point intervals. The MADRS total score is the sum of the 10 items and ranges from 0 to 60. A high numeric rating shows a greater degree of symptom severity. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christpher Kenney, MD | Biotie Therapies Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carmen Research | Atlanta | Georgia | 30080 | United States | ||
| Midwest Clinical Research Center |
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A total of 239 subjects were randomized into the trial from 19 of the 20 study sites initiated.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rufinamide | 500 mg 1 week, followed by 1000 mg for 7 weeks |
| FG001 | Placebo | 0 mg. tablet |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
ITT Population: Randomized and received at least one dose of the study drugs.
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| ID | Title | Description |
|---|---|---|
| BG000 | Rufinamide | 500 mg for 1 week followed by 1000 mg for 7 weeks |
| BG001 | Placebo | Placebo, 0 mg tablets |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change From Baseline in Hamilton Anxiety Scale (HAMA) - Total Score: Summary Statistics - Observed | The Hamilton Anxiety Scale is a 14-item test measuring the severity of anxiety symptoms. It provides measures of overall anxiety, psychic anxiety (mental agitation and psychological distress), and somatic anxiety (physical complaints related to anxiety). The interviewer then rated the individuals on a 5-point scale for each of the 14 items. Seven of the items specifically address psychic anxiety and the remaining 7 items address somatic anxiety. The total anxiety score ranges from 0 to 56. The 7 psychic anxiety items elicit a psychic anxiety score that ranges from 0 to 28. The remaining 7 items yield a somatic anxiety score that also ranges from 0 to 28. A score of 17 or less indicates mild anxiety severity. A score from 18 to 24 indicates mild to moderate anxiety severity, a score of 25 to 30 indicates a moderate to severe anxiety and lastly a score of 31-56 is very severe. HAM-A total score is the sum of items 1 - 14. | ITT Population: Randomized and received at least one dose of the study drugs. | Posted | Mean | Standard Deviation | score on a scale | 8 Weeks |
8 Weeks
Based on the Safety/Intent-to-Treat (ITT) population. This was defined as all randomized patients who received at least one dose of study medication.
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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 | Rufinamide | 500 mg for 1 week followed by 1000 mg for 7 weeks | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Bronchitis | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vision Blurred | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher Kenney, Senior Vice President - Medical Affairs | Acorda Therapeutics | 9143265775 | ckenney@acorda.com |
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| ID | Term |
|---|---|
| D000098647 | Generalized Anxiety Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C079703 | rufinamide |
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| Placebo | Drug | 0 mg tablets |
|
| 8 Weeks |
| Change From Baseline in Clinical Global Impression Scale for Severity of Illness: (CGI-S) | Severity of illness is the first scale in the CGI. A rating is filled in by the investigator at the start of treatment based on a 0-7 point weighted scale. It goes from not assessed (0), to among the most extremely ill patients (7). | 8 weeks |
| Change From Baseline Raskin Depression Scale. | It explores the extent to which an individual demonstrates depression on three sub-scales (rated 1-5): verbal self-report, behavior and secondary symptoms of depression. Scores range from 3-15, with higher scores indicating greater severity. | 8 weeks |
| Change From Baseline in Covi Anxiety Scale (CAS) - Index Total Score: Summary Statistics Observed | The Covi Anxiety Scale is a simple 3 item scale for the assessment of severity of anxiety symptoms. The scale measures 3 dimensions: verbal report, behavior and somatic symptoms of anxiety. Each item scored on a scale of 1 - 5. (1)not at all, (2)somewhat, (3)moderately, (4) considerably, and (5)very much), hence the scale is a 5- to 15 point range. The three items are the patient's verbal report (feeling shaky, jittery, jumpy), observed behavior consistent with anxiety during the interview (e.g. appearing frightened, shaky, restless) and somatic complains (e.g., sweating, trembling, heart pounding). COVI Rating Scale total score is the sum of items 1 - 3. | 8 weeks |
| Dayton |
| Ohio |
| 45408 |
| United States |
| 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 | Number | participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Rufinamide | 500 mg 1 week, followed by 1000 mg for 7 weeks |
| OG001 | Placebo | Placebo, 0 mg tablets |
|
|
| Primary | Change From Baseline in Hospital Anxiety and Depression Scale (HADS). Summary Statistics | The Hospital Anxiety and Depression Scale is a self screening questionnaire for depression and anxiety. It consists of 14 questions, seven for anxiety and seven for depression. The 14 statements are relevant to either generalized anxiety (7 statements) or 'depression' (again 7). Each question has 4 possible responses. Responses are scored on a scale from 3 to 0. The maximum score is therefore 21 for depression and 21 for anxiety. A score of 11 or higher indicates the probable presence of the mood disorder with a score of 8 to 10 being just suggestive of the presence of the respective state. The 2 subscales, anxiety and depression, have been found to be independent measures. In its current form the HADS is now divided into 4 ranges: normal (0-7), mild (8-10), moderate (11-15) and severe (16-21). Anxiety score = sum of items 1, 3, 5, 7, 9, 11, and 13. Depression score = sum of items 2, 4, 6, 8, 10, 12, and 14. | ITT Population: Randomized and received at least one dose of the study drugs. | Posted | Mean | Standard Deviation | score on a scale | 8 Weeks |
|
|
|
| Primary | Change From Baseline in Montgomery-Asberg Depression Scale (MADRS) Summary Statistics. | The MADRS (Montgomery and Asberg 1979) is a clinician-rated instrument that measures the presence and severity of depression. This instrument consists of 10 items. Each item is rated on a defined step scale of 0 to 6 with anchors at 2-point intervals. The MADRS total score is the sum of the 10 items and ranges from 0 to 60. A high numeric rating shows a greater degree of symptom severity. | ITT Population: Randomized and received at least one dose of the study drugs. | Posted | Mean | Standard Deviation | score on a scale | 8 Weeks |
|
|
|
| Primary | Change From Baseline in Clinical Global Impression Scale for Severity of Illness: (CGI-S) | Severity of illness is the first scale in the CGI. A rating is filled in by the investigator at the start of treatment based on a 0-7 point weighted scale. It goes from not assessed (0), to among the most extremely ill patients (7). | ITT Population: Randomized and received at least one dose of the study drugs. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
|
|
|
| Primary | Change From Baseline Raskin Depression Scale. | It explores the extent to which an individual demonstrates depression on three sub-scales (rated 1-5): verbal self-report, behavior and secondary symptoms of depression. Scores range from 3-15, with higher scores indicating greater severity. | ITT Population: Randomized and received at least one dose of the study drugs. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
|
|
|
| Primary | Change From Baseline in Covi Anxiety Scale (CAS) - Index Total Score: Summary Statistics Observed | The Covi Anxiety Scale is a simple 3 item scale for the assessment of severity of anxiety symptoms. The scale measures 3 dimensions: verbal report, behavior and somatic symptoms of anxiety. Each item scored on a scale of 1 - 5. (1)not at all, (2)somewhat, (3)moderately, (4) considerably, and (5)very much), hence the scale is a 5- to 15 point range. The three items are the patient's verbal report (feeling shaky, jittery, jumpy), observed behavior consistent with anxiety during the interview (e.g. appearing frightened, shaky, restless) and somatic complains (e.g., sweating, trembling, heart pounding). COVI Rating Scale total score is the sum of items 1 - 3. | ITT Population: Randomized and received at least one dose of the study drugs. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
|
|
|
| 115 |
| 1 |
| 115 |
| 75 |
| 115 |
| EG001 | Placebo | 0 mg tablet | 0 | 114 | 1 | 114 | 72 | 114 |
| Ecotopic Pregnancy | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
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| Dry Mouth | Gastrointestinal disorders | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | Systematic Assessment |
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| Joint sprain | Injury, poisoning and procedural complications | Systematic Assessment |
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| Decreased Appetite | Metabolism and nutrition disorders | Systematic Assessment |
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| Increased appetite | Metabolism and nutrition disorders | Systematic Assessment |
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| Athralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Sedation | Nervous system disorders | Systematic Assessment |
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| Somnolence | Nervous system disorders | Systematic Assessment |
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| Anxiety | Psychiatric disorders | Systematic Assessment |
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| Insomnia | Psychiatric disorders | Systematic Assessment |
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| Sinus congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding the study results for a period up to 30 days from the date the communication is submitted to the sponsor. The sponsor shall have the right to defer proposed publication an additional 60 days from the end of the review period. The sponsor cannot require changes to the communication and cannot unilaterally extend the embargo.
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| Last Observation |
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