Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study was terminated early due to low enrollment.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will explore the safety and efficacy of AGN201781 in patients with postherpetic neuralgia or post-traumatic peripheral neuralgia
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AGN201781 | Experimental | AGN201781 50 mg capsules three-time daily for 2 weeks |
|
| Placebo | Placebo Comparator | placebo 50 mg capsules three-times daily for 2 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AGN201781 | Drug | AGN201781 50 mg capsules three-times daily for 2 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Daily Pain Score at Week 2 | Change from baseline in the daily-average-pain score at week 2. This was measured using a 11-point (0 to 10) scale where 0 represented no pain and 10 represented worst pain. Due to the low number of patients completing the treatment period of the study no analyses were performed | Baseline, Week 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Subject Global Impression of Change Score at Week 2 | Change from baseline in Subject Global Impression of Change score at week 2. The Subject Global Impression of Change is a self-evaluation by the subject of their overall change in relief of neuropathic pain since the beginning of the study rated on a 7-point scale (1=very much improved to 7=very much worse). Due to low number of patients completing the treatment period of the study no analyses were performed. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Leonards | New South Wales | Australia | ||||
There were 2 Treatment Periods in this Cross-Over Study. Patients randomized to AGN201781 during Period 1 received Placebo during Period 2. Patients randomized to Placebo during Period 1 received AGN201781 during Period 2. Period 3 was an Observational Period only (No treatment provided).
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | AGN201781 Followed by Placebo | |
| FG001 | Placebo Followed by AGN201781 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| |||||||||||||
| Period 2 |
| |||||||||||||
| Period 3 |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | AGN201781 Followed by Placebo | |
| BG001 | Placebo Followed by AGN201781 | |
| BG002 | Total |
| 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 | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Change From Baseline in Subject Global Impression of Change Score at Week 2 | Change from baseline in Subject Global Impression of Change score at week 2. The Subject Global Impression of Change is a self-evaluation by the subject of their overall change in relief of neuropathic pain since the beginning of the study rated on a 7-point scale (1=very much improved to 7=very much worse). Due to low number of patients completing the treatment period of the study no analyses were performed. | Due to low number of patients completing the treatment period of the study no analyses were performed. | Posted | Baseline, Week 2 |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AGN201781 Followed by Placebo |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA (10.0) | Non-systematic Assessment |
This study was terminated early due to low enrollment (only 9 of the required 40 subjects had been enrolled). Due to the low number of patients who completed the treatment period of the study, no analyses were performed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Allergan, Inc. | 714-246-4500 | clinicaltrials@allergan.com |
Not provided
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| placebo |
| Drug |
placebo 50 mg capsules three-times daily for 2 weeks |
|
| Baseline, Week 2 |
| Kiel |
| Germany |
| NOT COMPLETED |
|
| NOT COMPLETED |
|
Total of all reporting groups
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| Primary | Change From Baseline in Daily Pain Score at Week 2 | Change from baseline in the daily-average-pain score at week 2. This was measured using a 11-point (0 to 10) scale where 0 represented no pain and 10 represented worst pain. Due to the low number of patients completing the treatment period of the study no analyses were performed | Due to low number of patients completing the treatment period of the study no analyses were performed | Posted | Baseline, Week 2 |
|
|
| 0 |
| 7 |
| 4 |
| 7 |
| EG001 | Placebo Followed by AGN201781 | 0 | 2 | 1 | 2 |
| Alanine aminotransferase increased | Investigations | MedDRA (10.0) | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA (10.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA (10.0) | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Leukocyturia | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Pityriasis rosea | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Renal pain | Renal and urinary disorders | MedDRA (10.0) | Non-systematic Assessment | Event occurred during Period 3 (Observational/No Treatment) |
|
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 40 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |