Safety and Efficacy of AGN201781 in Neuropathic Pain

This study has been terminated.

( This study was terminated early due to low enrollment. )

Study NCT00533351 Information provided by Allergan

First Received on September 19, 2007. Last Updated on December 15, 2011 History of Changes

Results First Received: December 15, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Crossover Assignment; Masking: Double Blind (Subject, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Neuralgia
Interventions:	Drug: AGN201781 Drug: placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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).

Reporting Groups

	Description
AGN201781 Followed by Placebo	No text entered.
Placebo Followed by AGN201781	No text entered.

Participant Flow for 3 periods

Period 1: Period 1

	AGN201781 Followed by Placebo	Placebo Followed by AGN201781
STARTED	7	2
COMPLETED	5	1
NOT COMPLETED	2	1

Period 2: Period 2

	AGN201781 Followed by Placebo	Placebo Followed by AGN201781
STARTED	5	1
COMPLETED	5	1
NOT COMPLETED	0	0

Period 3: Period 3

	AGN201781 Followed by Placebo	Placebo Followed by AGN201781
STARTED	3 ^[1]	0 ^[2]
COMPLETED	3	0
NOT COMPLETED	0	0

[1]	Three out of the five patients who completed Period 2 continued to Period 3
[2]	No patients continued to Period 3

Baseline Characteristics

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Reporting Groups

	Description
AGN201781	No text entered.
Placebo	No text entered.

Baseline Measures

	AGN201781	Placebo	Total
Number of Participants [units: participants]	7	2	9
Age [units: years] Mean ± Standard Deviation	60.6 ± 11.01	49 ± 36.77	54.8 ± 23.89
Gender [units: participants]
Female	5	0	5
Male	2	2	4

Outcome Measures

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1. Primary:

Change From Baseline in Daily Pain Score at Week 2 [ Time Frame: Baseline, Week 2 ]

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2. Secondary:

Change From Baseline in Subject Global Impression of Change Score at Week 2 [ Time Frame: Baseline, Week 2 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only 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 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.

Results Point of Contact:

Name/Title: Therapeutic Area Head
Organization: Allergan, Inc.
phone: 714-246-4500
e-mail: clinicaltrials@allergan.com

No publications provided

Responsible Party:	Allergan
ClinicalTrials.gov Identifier:	NCT00533351 History of Changes
Other Study ID Numbers:	201781-504
Study First Received:	September 19, 2007
Results First Received:	December 15, 2011
Last Updated:	December 15, 2011
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; Australia: Therapeutic Goods Agency