Study Details

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A study to evaluate the potential increased risk of seizures among Metastatic Castration-Resistant Prostate Cancer (mCRPC) patients treated with enzalutamide

This trial is complete
The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT01977651

Astellas Study ID

The unique identification code given by the study sponsor.

9785-CL-0403

EudraCT ID

The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).

2013-003022-92

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Condition

Prostate Cancer

Phase

These clinical trials happen after a drug or treatment has been approved for patients to take. Clinical trials in phase 4 usually take place over many years because researchers want to learn about long term use and safety of a drug or treatment.

Phase 4

Age

N/A - N/A

Sex

Male

Product

N/A

Type

A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

Interventional

Trial Dates

Sep 2013 - Jan 2019

Masking

None (Open Label)

Enrollment number

424

A Multicenter, Single-arm, Open-label, Postmarketing Safety Study to Evaluate the Risk of Seizure Among Subjects with Metastatic Castration-Resistant Prostate Cancer (mCRPC) Treated with Enzalutamide Who Are at Potential Increased Risk of Seizure

Study summary

Study documents

Study Documents, including study results, are available after a study is completed or terminated, according to Astellas Transparency policy.

Get More Information

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Locations

Site AU61009

Wahroonga, Australia, 2076

Site CA15001

Quebec City, Canada, G1R3S1

Site SE46002

Orebro, Sweden, 701 85

Site HU36004

Miskolc, Hungary, 3526

Site IL97205

Haifa, Israel, 31096

Site CZ42004

Praha 2, Czech Republic, 12000

Site AU61013

Adelaide, Australia, 5000

Site IT39003

Roma, Italy, 00144

Site DE49006

Tubingen, Germany, 72076

Site CL56004

Santiago, Chile, 8420383

Site FR33003

Cannes cedex, France, 06414

Site CA15005

Abbotsford, Canada, V2S 3N5

Site AU61004

Ballarat, Australia, 3350

Site US10026

Bronx, United States, 10461

Site FR33005

Suresnes, France, 92151

Site AU61001

Tweed Heads, Australia, 2485

Site CA15007

Kelowna, Canada, V1W 4V5

Site US10001

New York, United States, 10065

Site AR54002

Buenos Aires, Argentina, C1120AAT

Site IL97208

Nahariya, Israel, 21000

Site KR82007

Seoul, Republic of Korea, 03080

Site ES34005

Sabadell, Spain, 08208

Site ES34006

Madrid, Spain, 28050

Site BE32002

Roeselare, Belgium, 8800

Site BE32003

Liege, Belgium, B-4000

Site GR30001

Chania, Greece, 73300

Site NZ64002

Tauranga, New Zealand, 3140

Site TW88601

Kaohsiung, Taiwan, Province of China, 81362

Site HK85201

Shatin, Hong Kong

Site AU61011

Sydney, Australia, 2109

Site IL97206

Petah-Tiqva, Israel, 49100

Site US10008

Dallas, United States, 75231

Site CA15010

Scarborough, Canada, M1S 4V5

Site NZ64001

Hamilton, New Zealand, 3204

Site HU36002

Sopron, Hungary, 9400

Site DE49003

Berlin, Germany, 12200

Site AR54001

Berazategui, Argentina, B1880BBF

Site TW88603

Taipei City, Taiwan, Province of China, 10048

Site CL56002

Temuco, Chile, 4781156

Site ES34001

Pamplona, Spain, 31008

Site CA15002

Toronto, Canada, M5G 2M9

Site AR54006

Ciudad Autonoma de BuenosAires, Argentina, C1426ANZ

Site FR33002

Lyon Cedex 03, France, 69437

Site HU36001

Budapest, Hungary, 1082

Site SG65002

Singapore, Singapore, 119228

Site US10016

Durham, United States, 27710

Site AR54004

Santa Fe, Argentina, S3000FFU

Site IT39005

Meldola, Italy, 47014

Site FI35801

Oulu, Finland, 90220

Site IL97202

Kfar Saba, Israel, 44281

Site DE49009

Nürtingen, Germany, 72622

Site CA15013

Toronto, Canada, M4N 3M5

Site CL56001

Temuco, Chile, 4810469

Site US10013

Concord, United States, 28025

Site KR82001

Seoul, Republic of Korea, 135-720

Site FR33004

Rouen Cedex, France, 76031

Site ES34003

Barcelona, Spain, 08025

Site CA15004

Brampton, Canada, L6T 4S5

Site US10025

Seattle, United States, 98109

Site AR54005

Tucuman, Argentina, 4000

Site KR82004

Seoul, Republic of Korea, 137-701

Site KR82002

Seoul, Republic of Korea, 120-752

Site DE49001

Munster, Germany, 48149

Site US10024

Detroit, United States, 48202

Site GB44002

Sutton, United Kingdom, SM2 5PT

Site US10005

Anchorage, United States, 99503

Site CA15008

Toronto, Canada, M6A 3B5

Site IL97203

Beer-Sheva, Israel, 84101

Site KR82005

Seoul, Republic of Korea, 138-736

Site US10031

Lawrenceville, United States, 08648

Site AU61012

Kogarah, Australia, 2217

Site DE49002

Hamburg, Germany, 22399

Site IT39002

Arezzo, Italy, 52100

Site CL56003

Vina del Mar, Chile, 2540364

Site CA15014

Halifax, Canada, B3H 2Y9

Site DE49005

Mannheim, Germany, 68167

Site KR82006

Seongnam-Si, Republic of Korea, 013620

Site AU61007

Adelaide, Australia, 5042

Site AU61005

Randwick, Australia, 2031

Site SE46001

Goteborg, Sweden, 41345

Site IT39001

Cremona, Italy, 26100

Site BE32004

Anderlecht, Belgium, 1070

Site US10014

New York, United States, 10065

Site CZ42002

Praha 6, Czech Republic, 16000

Site AU61002

Nambour, Australia, 4560

Site AR54003

Cordoba, Argentina, 5000

Site IL97201

Be'er Ya'akov, Israel, 70300

Site US10004

San Diego, United States, 92123

Site FI35803

Helsinki, Finland, 00290

Site ES34004

Barcelona, Spain, 08035

Site DE49004

Göttingen, Germany, 37075

Site IL97204

Jerusalem, Israel, 91120

Site IL97207

Ramat Gan, Israel, 52621

Site ES34007

Hospitalet de Llobregat, Spain, 08908

Site KR82003

Seoul, Republic of Korea, 135-710

Site US10032

Albuquerque, United States, 87109

Site US10039

Syracuse, United States, 13210

Site BE32001

Kortrijk, Belgium, 8500

Site FI35802

Tampere, Finland, 33520

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