Expanded Access Program (EAP) for Nusinersen in Participants With Infantile-onset (Consistent With Type 1) Spinal Muscular Atrophy (SMA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02865109|
Expanded Access Status : No longer available
First Posted : August 12, 2016
Last Update Posted : April 5, 2021
|First Submitted Date||August 10, 2016|
|First Posted Date||August 12, 2016|
|Last Update Posted Date||April 5, 2021|
|Brief Title||Expanded Access Program (EAP) for Nusinersen in Participants With Infantile-onset (Consistent With Type 1) Spinal Muscular Atrophy (SMA)|
|Brief Summary||To provide access to nusinersen to eligible patients with Infantile-onset Spinal Muscular Atrophy (SMA) (consistent with Type 1) to address a high-unmet medical need.|
The nusinersen expanded access program (EAP) is available at approved treatment centers in select territories.
A doctor must decide whether nusinersen treatment is appropriate for each patient, based on the patient's medical history and program eligibility criteria. A full list of participating treatment centers is provided in the 'Contacts and Locations' section of this listing, and is regularly updated.
Following local approval and official reimbursement of nusinersen in each territory, the EAP will close and patients will transfer to commercially available drug.
|Study Type||Expanded Access|
|Expanded Access Type||Treatment IND/Protocol|
Administered by intrathecal injection
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Expanded Access Status||No longer available|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||Colombia, New Zealand, Turkey|
|Removed Location Countries||Australia, Austria, Belgium, Canada, China, Denmark, Finland, France, Germany, Greece, Ireland, Israel, Italy, Korea, Republic of, Mexico, Netherlands, Norway, Poland, Portugal, Slovenia, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States|
|Verification Date||March 2021|